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Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
Sponsor: Amgen
Summary
The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.
Official title: Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2024-07-17
Completion Date
2032-04-25
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
FOLFIRI Regimen
Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
Sotorasib
Immediate-release solid dosage form administered orally.
Panitumumab
Administered via IV infusion Q2W.
Bevacizumab-awwb
Administered via IV infusion Q2W.
Locations (291)
Ironwood Cancer and Research Centers Scottsdale
Chandler, Arizona, United States
Providence Saint Jude Medical Center
Fullerton, California, United States
City of Hope National Medical Center
Long Beach, California, United States
Cancer and Blood Research Center, LLC
Los Alamitos, California, United States
California Research Institute
Los Angeles, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Cancer Specialists of North Florida - Southpoint
Jacksonville, Florida, United States
D and H Cancer Research Center
Margate, Florida, United States
Mid Florida Hematology and Oncology Centers PA
Orange City, Florida, United States
Boca Raton Clinical Research Medical Center Inc
Plantation, Florida, United States
Georgia Cancer Specialists
Atlanta, Georgia, United States
Insight Research Institute
Chicago, Illinois, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Orchard Healthcare Research Inc
Skokie, Illinois, United States
Pikeville Medical Center
Pikeville, Kentucky, United States
Henry Ford Health System
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Saint Louis Cancer Care West County
Bridgeton, Missouri, United States
Minniti Center for Medical Oncology and Hematology
Mickleton, New Jersey, United States
Duke Cancer Center
Durham, North Carolina, United States
FirstHealth Cancer Center
Pinehurst, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Carolina Blood and Cancer Care
Rock Hill, South Carolina, United States
Tennessee Oncology PLLC - Chattanooga
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Hospital Universitario Fundacion Favaloro
CABA, Buenos Aires, Argentina
Instituto Argentino de Diagnóstico y Tratamiento
CABA, Buenos Aires, Argentina
Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL
CABA, Buenos Aires, Argentina
Cemic
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Sanatorio Británico de Rosario
La Plata, Buenos Aires, Argentina
Instituto de Investigaciones clinicas de Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Hospital Italiano de Córdoba
Córdoba, Córdoba Province, Argentina
Sanatorio Allende
Córdoba, Córdoba Province, Argentina
Clinica Universitaria Privada Reina Fabiola
Córdoba, Córdoba Province, Argentina
Clinica Viedma
Viedma, Río Negro Province, Argentina
Exelsus Oncologia Clinica
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina
Centro Oncologico Riojano Integral
La Rioja, Argentina
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Austin Health, Austin Hospital
Heidelberg, Victoria, Australia
Medizinische Universitaet Graz
Graz, Austria
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria
Landeskrankenhaus Feldkirch
Rankweil, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, Austria
Krankenhaus Wiener Neustadt
Wiener Neustadt, Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, Belgium
Institut Jules Bordet
Brussels, Belgium
Grand Hôpital de Charleroi - Site des Viviers
Charleroi, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium
Algemeen Ziekenhuis Sint Maarten-Emmaus vzw
Mechelen, Belgium
AZ Delta Campus Rumbeke
Roeselare, Belgium
Vitaz campus Sint-Niklaas Moerland
Sint-Niklaas, Belgium
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Hospital Sirio Libanes Brasilia
Brasília, Federal District, Brazil
Vencer e Oncoclinica
Teresina, Piauí, Brazil
Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, Brazil
Fundacao pio xII Barretos
Barretos, São Paulo, Brazil
Oncoclinicas Belo Horizonte
Barretos, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Fundacao Antonio Prudente AC Camargo Cancer Center
São Paulo, São Paulo, Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, Brazil
Instituto Cancer Sao Paulo Icesp
São Paulo, Brazil
Instituto Brasileiro de Controle do Cancer Ibcc
São Paulo, Brazil
Oncologia Rede D Or
São Paulo, Brazil
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
Haskovo, Bulgaria
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv, Bulgaria
Complex Oncology Center Plovdiv EOOD
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment Serdikamed EOOD
Sofia, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, Bulgaria
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
William Osler Health System - Brampton Civic Hospital
Brampton, Ontario, Canada
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
James Lind Centro de Investigacion del Cancer
Temuco, Cautín, Chile
Centro de investigacion y desarrollo oncolgico Spa
Temuco, Cautín, Chile
Enroll SpA
Providencia, Santiago Metropolitan, Chile
Clinica Redsalud Vitacura, Instituto del Cancer
Vitacura, Santiago Metropolitan, Chile
Fundacion Arturo Lopez Perez
Santiago, Chile
Centro de Oncologia de Precision (Medicina de Precision Celerity)
Santiago, Chile
Biocinetic servicios medicos limitada
Santiago, Chile
Clinical Research Chile SpA
Valdivia, Chile
Servicios de Salud Ips Suramericana Sas - Ips Sura Industriales
Medellín, Antioquia, Colombia
Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
Rionegro, Antioquia, Colombia
Instituto Nacional de Cancerologia
Bogota, Cundinamarca, Colombia
Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
Bogotá, Cundinamarca, Colombia
Instituto Medico de Alta Tecnologia sas - Imat sas
Montería, Departamento de Córdoba, Colombia
Fundacion Oftalmologica de Santander - Foscal
Floridablanca, Santander Department, Colombia
Masarykuv onkologicky ustav
Brno, Czechia